Night Shift Senior Bioprocess Operator

KBI Biopharma, Inc.; Durham (NC); On-site; USD 85,000 - 110,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Senior Manufacturing Associate II for the Nights shift to perform downstream processing of bulk intermediates and drug substances, adhering to GMP and GLP with proper documentation.

The role includes authoring SOPs/MBRs, writing CAPAs, and qualifying new equipment, while collaborating with QA, MS&T, facilities, engineering, and supply chain to ensure reliable, compliant operations.

Qualifications

• Bachelor’s degree in a related scientific or engineering discipline with 5+ years’ GMP manufacturing experience.
• High school diploma with 10+ years GMP manufacturing experience.
• Experience with downstream unit operations preferred.
• Strong written and verbal communication skills.

Responsibilities

• Manufacture bulk intermediates and drug substances per batch records in compliance with quality standards.
• Operate in a cleanroom environment with aseptic processing controls.
• Document each task in manufacturing records and logbooks per GDP.
• Maintain and service equipment per applicable SOP.
• Ensure materials are issued and accounted for during record execution.
• Demonstrate understanding of cGMP and its application.
• Participate in workplace organization (5S).
• Provide direction to Manufacturing Associates and assist supervisor with workload distribution.

Skills

GMP manufacturing

Written communication

Verbal communication

Problem solving

Education

Bachelor’s degree in science or engineering

High school diploma with 10+ years GMP experience

Tools

ERP

MS Office

EDMS

Job description

KBI Biopharma, Inc. is seeking a Senior Manufacturing Associate II for the Nights shift to perform downstream processing of bulk intermediates and drug substances, adhering to GMP and GLP with proper documentation.

The role includes authoring SOPs/MBRs, writing CAPAs, and qualifying new equipment, while collaborating with QA, MS&T, facilities, engineering, and supply chain to ensure reliable, compliant operations.